His-pacing and AV-node Ablation vs. Pulmonary Vein Isolation for Atrial Fibrillation

NCT04512586 | Terminated

• 1 other identifier: His_PAAF_study
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 4

Brief Summary

Objective To investigate if conduction system pacing ((CSP) i.e. atrioventricular node ablation + His bundle pacing or Left Bundle Branch pacing) is as good as (or better than) atrial fibrillation ablation with pulmonary vein isolation for older patients (70-85yrs) with symptomatic atrial fibrillation and at least moderately dilated left atrium. Patient population: 90 patients aged 70-85 years with atrial fibrillation, referred to either AV node ablation or pulmonary vein isolation. Primary endpoint: Improvement in health-related quality of life as measured by the physical component summary (PCS) of the well-validated SF-36 form, at one year after AV node ablation + CSP or AF ablation. Secondary endpoints: Physical performance measured by 6-minute walk test, biochemical markers of heart failure (NT-ProBNP), frequency of complications, left ventricular systolic and diastolic function, and left atrial size evaluated after 12 months. Arrhythmia specific symptoms and anxiety will be measured with the ASTA and HADS questionnaires. Arrhythmia symptom correlation between subjective and objective findings. After three years, clinical endpoints will be evaluated regarding overall survival, and risk of heart failure hospitalization or death. The cost of the treatments will be compared, and estimated cost per quality adjusted year of life will be calculated, based on the EQ5D questionnaire.

Conditions

Atrial Fibrillation; Left Atrial Dilatation

Keywords

Atrial fibrillation; Left atrial dilatation; Pulmonary vein isolation; AV node ablation; Conduction System pacing; Quality of Life; Age group 70 to 85 years

Outcome Measures

Primary Outcomes (1)

• Health related Quality of Life: questionnaire

  Improvement in the Physical Component Summary (PCS) of the SF-36 questionnaire

  12 months

Secondary Outcomes (11)

• Safety endpoint: Proportion of patients with major adverse events

  12 months

• Mental Quality of Life: questionnaire

  12 months

• Arrhythmia related Quality of Life: ASTA questionnaire

  12 months

• Anxiety and depression

  12 months

• Ejection fraction

  12 months

Study Arms (2)

Conduction System pacing plus AV node ablation

EXPERIMENTAL

A His-pacing lead in combination with a backup RV pacing lead or an LBB pacing lead, and a right atrial lead (if needed) will be placed using standard technique. The His-pacing or LBB pacing lead will be Medtronic 3830, and the outer sheath will be either Medtronic C304 or C315 deflectable. If failure to implant with these tools, other leads and sheaths can be used at the discretion of the operator. A standard DDD pacemaker or CRT-P device from Medtronic will be used. A minimum of three weeks post-implant, the device will be interrogated and His-bundle threshold will be evaluated. A threshold of ≤2.0V@1.0ms is acceptable. If the device is well-functioning and successful His-pacing is documented, AV node ablation will be performed.

Procedure: Conduction System pacing and AV node ablation

Pulmonary vein isolation

ACTIVE COMPARATOR

Atrial fibrillation will be performed as a complete pulmonary vein isolation. Either Cryoballon or radio frequency ablation with irrigated tip contact force enabled catheter can be used. Pulsed field ablation can be used if available. Endpoint is complete electrical isolation of all pulmonary veins, verified by entry- and exit block using a multipolar catheter during pacing.

Procedure: Atrial fibrillation ablation by pulmonary vein isolation

Interventions

Conduction System pacing and AV node ablation PROCEDURE

See study arm description.

Conduction System pacing plus AV node ablation

Atrial fibrillation ablation by pulmonary vein isolation PROCEDURE

See study arm description

Pulmonary vein isolation

Eligibility Criteria

• Age: 70 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Indication for invasive treatment of symptomatic atrial fibrillation according to current guidelines
• LVEF \>35%
• Age 70-85 years
• Persistent atrial fibrillation, or paroxysmal atrial fibrillation with at least moderate enlargement of the left atrium (≥42ml/m2)
• Chronic and well-tolerated treatment with anticoagulants (either non-vitamin K oral anticoagulant or vitamin K antagonist)
• Willingness to participate, to understand the instructions and fill out the questionnaires, and ability to sign informed consent

You may not qualify if:

• Chronic atrial fibrillation with \>1 year duration
• BMI \>40kg/m2
• Hypertrophic cardiomyopathy
• Severe heart failure with symptoms ≥ NYHA class IIIb
• Heart amyloidosis
• Cardiac sarcoidosis
• Recent (\<3 months) myocardial infarction
• Significant heart valve disease (pronounced insufficiency or stenosis)
• Pacemaker or ICD treatment ongoing, or current pacemaker indication
• Congenital heart disease that required surgical correction
• Comorbidity that is assessed significantly affect the patient's quality of life over the next year, or 3-year survival

Sponsors & Collaborators

• Region Skane: lead

Study Sites (4)

Linköping University

Linköping, Sweden

Location

Skane University Hospital

Lund, 221 85, Sweden

Location

Stockholm Arrhythmia Center

Stockholm, Sweden

Location

Varberg Hospital

Varberg, Sweden

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rasmus Borgquist, MD PhD

  Lund University, Skane University Hospital, Arrhythmia Section, Lund, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are randomized to either 1. Conduction system pacing via His-pacing electrode, in combination with AV node ablation 2. Pulmonary vein isolation ablation

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: August 13, 2020
• Study Start: September 1, 2020
• Primary Completion: February 26, 2025
• Study Completion: February 26, 2025
• Last Updated: March 4, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)